OncoMatch/Clinical Trials/NCT05765500
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Is NCT05765500 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Relugolix and Leuprolide for prostate cancer.
Treatment: Relugolix · Leuprolide — This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label. The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT)
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: GnRH agonist or antagonist
Participants cannot have received prior GnRH agonist or antagonist therapy.
Cannot have received: second generation androgen receptor targeted therapy (abiraterone, enzalutamide, darolutamide, apalutamide)
Participants who have prior or planned concurrent treatment with second generation AR targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide).
Lab requirements
Blood counts
leukocytes ≥3,000/mcL; absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL
Kidney function
creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome; AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
Cardiac function
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Participants must have adequate organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * creatinine ≤ institutional ULN OR * glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B). Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Dana-Farber Cancer Institute at Foxborough · Foxborough, Massachusetts
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